Thursday, November 26, 2015

Gilead's Counsel Has Answered Merck Counsel's Claim: No "Crime Or Fraud" Exception Applies -- In Sovaldi® Patent Wars

I am a little late in posting this, with the holiday busy-ness, and airport runs -- but it took Gilead's legal team only one elapsed day to reply to Merck's lawyers (detailed here, and here -- previously).

In sum, Gilead says the disputed emails were in fact privileged communications -- from a predecessor-entity officer, to outside counsel, and thus are properly the subject of a claw-back order. Moreover, Gilead's counsel says Merck never really articulated any plausible crime or fraud theory -- let alone offered prima facie evidence of it -- so, it all should amount to. . . nothing.

Of course, because both documents are heavily redacted, we have no way of evaluating these arguments, and counter arguments. We are just reporting them. Here is that latest six page Gilead PDF letter -- with all of its various redactions -- and a bit:

. . . .Simply put, neither Gilead nor its predecessor Pharmasset committed any crime or fraud, nor have Plaintiffs shown that they have. The crime-fraud exception requires that Plaintiffs "make a prima facie showing that (1) the client was committing or intending to commit a fraud or crime, and (2) the attorney-client communications were in furtherance of that alleged crime or fraud." In re Chevron Corp., 633 F.3d 153, 166 (3d Cir. 2011) (internal citations omitted). Plaintiffs have shown neither. Plaintiffs have not and cannot show: (1) that any fraud was, in fact, committed; and (2) that Pharmasset had any intent to perpetrate a fraud.

The court applies a "reasonable basis" standard to assess the sufficiency of the required prima facie showing, generalized allegations of fraud are not sufficient, rather the proponent of the exception must provide the “requisite factual basis” for the crime-fraud exception to apply. In re ML-Lee Acquisition Fund II, L.P. & ML-Lee Acqueistion Fund (Ret. Accounts) II, L.P. Sec. Litig., 848 F. Supp. 527, 566 (D. Del. 1994); See also Manetar Tech. Corp. v. Six Flags Theme Park, Inc., 886 F.Supp.2d 466, 487 (D. Del. 2012) (noting that to "demonstrate a prima facie case of fraud" sufficient to sustain the crime-fraud exception’s application, "generalized allegations… will not suffice"). That factual basis must include the relevant intent evidence. See, e.g., Finley Assocs., Inc. v. Sea & Pines Consol. Corp., 714 F. Supp. 110, 118 (D. Del. 1989) (noting that the party requesting the crime-fraud exception’s application must “present[] a reasonable basis for believing that the [client’s] objective was fraudulent”) (emphasis added). Plaintiffs fail wholly to meet their burden.

As a threshold matter, Plaintiffs never identify the elements of the fraud or crime they allege. . . .

Now the very able Judge Stark will have to decide: are the emails excluded from evidence, and thus not available for any purpose, in the global perhaps multi-billion dollar litigation? Or, may Merck make hay out of what may have been some intemperate remarks, by a Pharmasset science officer, many, many years ago? We will have to wait and see -- our best -- to all of good will, and good cheer!

Wednesday, November 25, 2015

Some Blood Pressure Numbers To Contemplate -- Over Your Turkey, Stuffing, Gravy And Sweet Potato Pie... Not Really O/T

I won't offer a long wind up here -- just mostly point you to a terrific post over at MedNewsToday -- by Alan Cassels. [Graphic at right is his summarized fine work, as to all the content -- ours, as to the derivative styling. Click to enlarge.]

Much was made last month -- of the very large SPRINT blood pressure study results, purporting to support the thesis of "even lower" is better -- or, "ever lower" if you prefer -- for reducing cardiovascular risks. Cassels has admirably offered us the flip side -- the numbers needed to harm -- when a two-, or three-drug regimen drives those numbers down -- very, very low. Kidney problems -- up to and including renal failure -- emerge as one of those off-target effects, as providers ramp up the dosages. Do read all of his -- but these are his takeaways:

. . . .I decided to construct my own table using the individual Secondary Outcomes and Serious Adverse Effects that were found to be ‘statistically significant’ (i.e.: had a P-value lower than 0.05). As you see in the list below, here’s how many people need to be treated to be helped or harmed in the “intensive” blood pressure group compared to “standard” therapy:

125: Number needed to treat to prevent one case of heart failure.

167: Number needed to treat to prevent one death by cardiovascular causes

83: Number needed to treat to prevent death by any cause

100: Number needed to harm to cause one case of hypotension

167: Number needed to harm to cause one case of syncope

125: Number needed to harm to cause one case of electrolyte abnormality

56: Number needed to harm to cause one case of acute kidney injury or renal failure

42: Number needed to harm to cause one serious adverse event. . . .

Those rather low numbers needed to harm, at higher dosages -- should give us all pause. So -- do take the NEJM Sprint article with this in mind, as you settle into your easy chair, after that second helping of bacon-infused smoky turnip greens and buttery cornbread. I know I will. Safe and Happy Holidays, to all! I'm off. . . .

Tuesday, November 24, 2015

Seems It's Gotten Nasty, Between Gilead And Merck: With Allegations Of Crimes -- Sovaldi® Patent Wars

Well, this is not something you run across every darn day. . . But first off -- the caveats: I will offer no opinion on the merits of these claims or counter claims. I will simply report on them -- from an entirely public court filing, in the federal District courthouse, in Delaware -- just this very morning.

Secondly, it is very hard to infer very much, here -- since the documents in question are largely blacked out (redacted), at the key passages.

However, it is plain that Merck's counsel is at least alleging that the e-mails Gilead seeks to "claw back" -- ones that Gilead claims were inadvertently produced (in an earlier backgrounder of mine, here, as early as May of 2015) -- concern a predecessor to Gilead offering instuctions "made for an improper purpose and in furtherance of a crime or fraud. . . ." In plainer English, then, the claim is that an agent for Gilead's prior entity was trying to deceive the patent authorities, and apparently trying to do so, about Merck's allegedly earlier prior art. But that last little bit is really a guess.

I attach here a PDF of the whole four-page letter, with all redactions, so that my readers may judge for themselves -- but this fight has suddenly turned especially nasty. [Editorial note: in the syntax of that letter, Idenix is the prior entity in interest, to Merck, here.]

We will, of course, keep you posted as this develops -- and will update if/when the court in Delaware rules on the clawback motion, proper. But that is. . . just ugly, IMHO -- as the truth sometimes. . . turns out to be. I'll have a more sunnily-themed post tomorrow, I am sure. Onward.

Monday, November 23, 2015

"Pfilergan" Update: "Execution Risk"? In A Flat Market, BOTH Target And Acquiror Fell Significantly -- Announcement Day

Of course the strong declines could be chalked up to a variety of external events -- but a falling overall market today won't be one of them. We may also safely eliminate a "pre-deal" run-up in either name -- for there wasn't one. Finally, I'll note that it is highly unusual -- for a deal of this size not to see at least one of the two participants' stocks show at least a modest pop -- on announcement day. [Fancy that, Mr. Read. . . .]

Personally, I do see some real "execution risks" to getting this deal done -- on anything like the terms announced today (and at the projected correlative synergy values). And so it is at least possible that the 3.44 per cent decline in Allergan's stock, and the 2.64 per cent decline in Pfizer's, reflects a discount -- which I'll label an execution risk discount.

I went out on a limb last night, and guessed that the election year US tax howling will -- in one way or another, eventually strip most of the tax inversion benefit away from this deal. I think the broader market thinks that, now, too.

In prior widely-reported remarks, Mr. Read had indicated that he would likely "still do" the Allergan deal -- even without the inversion tax benefits -- but he plainly also said it would be "at a different [i.e., lower] value."

Some version of that event risk -- coupled to at least some antitrust risk, globally, may well explain today's trading in these two now floating merger arbitrage stocks. Enjoy your pre-holiday cooking nights, one and all. . . Onward!

Sunday, November 22, 2015

"Pfilergan" 2016: I'll Go Out On A Limb, And Bet That The Inversion Aspect Of This Deal Will Be Scuttled

With unnamed sources reporting tonight that Brent Saunders will secure an integration-related role, and perhaps be in line to take Mr. Read's seat, one day. . . I imagine the respective boards are in fact meeting tonight.

If that turns out to be true, I'd look for a doozy of an early 2016 tax policy fight here, in the US. No one currently running for President will be happy with Mr. Read's move. Of course, we may safely except the current shareholders of Pfizer -- from those who will howl -- but not many more. And, as I will make plain in some later post, when I have more time, Mr. Read grossly overstates his US tax burden, largely for the purpose of forcing the inversion discussion. [UPDATED: I've just made my whimsical suggestion, at left, for the combined entity's logo.]
But as I say, more on that, some other day -- if and when a deal is announced formally. Here is the New York Times, on the latest rumors:

. . . .The boards of Pfizer and Allergan are set to approve a merger of the two companies worth more than $150 billion, people briefed on the matter said on Sunday.

A merger would create a huge new pharmaceutical giant and could potentially help Pfizer lower its American tax rate.

Directors of both companies were expected to vote on the transaction Sunday, with an announcement expected as soon as Monday, the people said, noting that final details were still being settled and the timing could change.

Under terms of the proposed deal, Pfizer is expected to pay 11.3 of its shares for each share of Allergan, the maker of Botox, which has its headquarters in Dublin. The transaction would also involve a relatively small cash component.. . .

Wondering if there will be some official word -- smoke signals, or other -- tomorrow. . .on this? Smiling, just the same. . . sleep soundly, like little round river rocks, one and all!

Friday, November 20, 2015

Liberia Reports First New Ebola Cases In Three Months

Sad and surprising news to report -- from Africa: even as Guinea has begun a "disease arrested" countdown to December 18, 2015 (according to W.H.O.), a surprise Ebola infection case -- this time, of a ten year old boy -- appeared literally overnight, in Liberia. UPDATED: two of his family members are also infected, according to New York Times reporters -- in tomorrow's print edition. That brings the new total to three.

In one other shining bit of good news, though -- Sierra Leone remains disease free.

It is -- as with all epidemics -- two steps ahead; one back -- but the trend is clearly encouraging. From this morning's New York Times, then -- a bit:

. . . .Three members of a family in Liberia have contracted Ebola, two months after the country was declared free of the virus, health officials said on Friday.

The first documented case in the family was a 10-year-old boy who started showing symptoms last week, said a Liberian health official, speaking on the condition of anonymity.

After attending school on Monday and Tuesday, the boy was admitted to a hospital and was transported to an Ebola treatment unit on Wednesday, the official said.

The boy’s test came back positive on Thursday, as did subsequent tests for his father and a sibling, the official said, adding that at least seven health care workers may have treated him without the protective equipment essential for Ebola cases. The World Health Organization declared Liberia free of Ebola on May 9, but a resurgence of the disease the next month sickened four people, two of whom died. The country was declared Ebola-free again on Sept. 3. . . .

My recent Liberia backgrounder here. As with all difficult, but life affirming scientific endeavors, we remain optimistic, and confident: new life -- new hope -- will. . . inexorably prevail. Onward, toward a holiday-shortened next week. Do treat one another well.

Thursday, November 19, 2015

Twin Updates -- In Delaware, and Northern California -- Regarding Merck Vs. Gilead Sovaldi® Patent Litigation

First off, in a pair of sealed letters (only the titles of which we may view -- from the electronic PACER docket screens), we learn that the parties are now fighting over some emails that were allegedly inadvertently turned over in discovery. It seems that Gilead earlier turned over a cache of emails to Idenix/Merck, and now their lawyers want them back. One letter seeks to "claw back" the would-be errant emails, while the second (predictably) seeks to prevent that claw back order. We may never know what these emails actually said, but we will eventually see whether the claw back is allowed, in a public order entry.

Separately, on the other side of the nation, the date and time for motions to compel witnesses to answer -- partly on those vials we discussed last month -- have been reset to late in the day, Pacific time (Gilead's reply was here). They will be heard in an after-hours session, on December 1, 2015 -- in San Jose's federal District Courthouse. I suspect the 4:45 PM PST start time is to allow for the court room to be cleared, as some of this will surely involve trade secrets, and arguments about those secrets. I'd expect that the hearing might last until nearly 8 PM, Pacific Standard Time, that evening. We will report on the outcome of both of these matters, when the electronic docket is updated. Here is the text of the california one:

. . . .CLERK'S NOTICE RESETTING TIME ON DECEMBER 1, 2015 MOTION HEARING, resetting time as to [156] MOTION to Compel regarding Dr. Alexander Clemens and [158] MOTION to Compel Plaintiff and Dr. Seeger to Comply with Discovery Requests and Subpoena: 12/1/2015 10:00 AM Motion Hearing is reset to 4:45 PM (SPECIAL SET) in Courtroom 5, 4th Floor, San Jose before Magistrate Judge Paul Singh Grewal. . . .

Now you are right up to date, on the Sovaldi® patent spats. Onward!

Wednesday, November 18, 2015

"UN-Shrug-Worthy?" Bloomberg's Gadfly Blogger Takes Old Line Big Pharma To Task, Too -- On Pricing

This is but one of the stories I missed mentioning, while otherwise occupied earlier this week. It is a meta-narrative line I've written about countless times, over these past seven or so years (that linked one considers the "moral suasion" angle). But here was the latest, along these lines, from last month. It is a timeless, intractable and yet ever-current topic, no doubt. Sort of like I don't know. . . birth, death and. . . taxes.

The latest voice in this particular meta-narrative arises from a self-styled "gadfly blogger" at Bloomberg has added to the din -- on pricing -- in a pretty rational fashion, to my way of thinking. Do go read it all, but here is a bit:

. . . .[P]rice increases on older drugs are an essential profit driver across the industry. Last year, according to Credit Suisse, 80 percent of net profit growth among 20 of the largest companies came from price increases. Merck has raised prices on 38 brand name drugs this year and Pfizer on 133. Last year, driven in large part by a new generation of Hepatitis C drugs, U.S. drug prices rose 13 percent, the biggest increase in a decade and far, far ahead of inflation. . . .

Most executives seem to assume that nothing in the way of legislation will come of all this fuss in the end. "I think you have to separate a little bit of the rhetoric and the newspaper reports from the fact that I think there's a lot of rationality in public policy," Merck's Frazier said on the earnings call.

Translated? I talked to the folks in Washington, and they're not really going to do much of anything. . . .

I suspect Mr. Frazier is right -- even when Mrs. Clinton is elected as. . . No. 45. But the blogger above does have a point: a price spiral always -- always! -- breaks at some point; usually violently, often precipitously, but without fail in a capitalist system as ours is -- that day is. . . coming. Sleep well, one and all!

UBS Analysis: Merck, AbbVie Next Gen Hep C Candidates (Due in 2016) Not Likely A Big Threat To Gilead's Franchises

So sorry. Oh my. I've been busy elsewhere in the world, so forgive the delay in postings. . . with a little luck, I'll be back on track after Friday.

UBS analysts are being quoted in a Forbes blog -- from the floor of the AASLD, just wrapping -- but do go read it all:

. . . .Based on the C-CREST eight week data, we think Merck has to go to tweleve weeks to get to high SVR’s across genotypes. We see the (Merck) Graz/Elba doublet as less of a threat considering expert questions on persistent ALT elevations, and poor performance in patients with baseline RAVs. AbbVie’s next-gen looks good thus far, albeit in easier patients. In contrast, Gilead’s ASTRAL dataset was a shock-and-awe campaign with very high SVR’s across all six genotypes, including decompensated cirrhotics. This sets a much higher bar for next-gen regimens, which at some point may need to show non-inferiority to gain FDA approvals (as seen in HIV). . . .

Seamus Fernandez at Leerink Swann sees Merck with a shot at being No. 2 in the next gen Hep C space -- taking the seat now held (current gen) by AbbVie -- for what that is worth. So -- now you know! Onward, on a busy working week. Be excellent to one another. . . .

Friday, November 13, 2015

Largely As Expected -- Merck Is Clear On Cubicin® -- Through June 2016, At Least

First and foremost, say a prayer for the good and courageous people of Paris, tonight. They need our spiritual support.

The Federal Circuit panel has just made it clear that Merck will control the central patent on Cubicin® (Daptomycin) -- until at least late-June of 2016. Here is my last backgrounder, on this topic -- from about four weeks ago. Now that opinion is available.

In doing so, it sided with the federal District (trial level) court, and invalidated three of the four patents held by Cubist/Merck -- those reaching into 2019 -- for obviousness. But Wall Street was largely expecting this.

Now the question is whether Merck will seek a rehearing en banc, or appeal to the US Supremes -- or let it go, and gear up for 2016 competition from Hospira -- now owned by Pfizer.

We will let you know. I'll put the full 32 page PDF of the opinion here.

Onward, one and all, bending but not broken -- have a safe and reflective weekend. . . .

Merck Animal Health Quietly Acquires Privately-Held Harrisvaccines -- Terms Withheld

I think this latest news may be safely read as more consolidation among newer franchises, in the AH space, broadly -- and as a deal that gives Merck access to some newer vaccine tech and product candidates -- more narrowly, as it looks for an edge, in competing with the 2013 era Pfizer AH spinoff, Zoetis.

The purchase price will be completely immaterial to Kenilworth, as 45 employees would imply a low- to mid- double digits of millions price, as a pure guess. However, in the longer run, the fold in to animal vaccines may well-position the group -- as additional consolidating deals among global animal health manufacturers are quite likely, in my view. Here's the relevant bit, courtesy the overnight Des Moines Register:

. . . .Joel Harris, a vice president with Harrisvaccines, said the 10-year old company has been openly considering offers in the last year in order to help it enhance its ability to grow.

He said the vaccine manufacturer would benefit from Merck’s resources to expand its technology into other areas such as foot-and-mouth-disease in cattle and canine influenza in dogs.

The companies did not disclose the terms of the deal, including the purchase price. Harrisvaccines, which currently employs about 45 full-time people, does not expect any job cuts.

Harrisvaccines was the first company to get approval in 2014 for a vaccine to help protect piglets from the porcine epidemic diarrhea virus that killed millions of pigs in more than 30 states, including Iowa, the country’s largest pork producer. And last month it announced it was awarded a $6 million contract to provide 48 million doses of its bird flu vaccine to the USDA. . . .

We will keep an eye on this, but it ought to close before year end, as there are no Hart-Scott filings, or issues. Enjoying a weekend visit with a nephew, out on a college recruiting trip. . . so, keep it spinning in good karma, one and all!

Thursday, November 12, 2015

Excellent News! Pauline Cafferkey Has Recovered -- Again!

With the latest Ebola Situation Report confirming that there are no new cases this week in Guinea, this is a week of almost exclusively good news -- globally, on the topic.

Overnight in London, the Scottish nurse who had last month been critically ill for a second time, with a form of menigitis caused by her prior Ebola bout -- has been released from hospital, apparently with the help of an experimental Gilead candidate. This is very encouraging, indeed. Our backgrounder is here -- and the Gray Lady, on it all:

. . . .The nurse, Pauline Cafferkey, contracted Ebola last year while doing charity work in Sierra Leone and recovered for the first time in January. Last month, she again fell critically ill from the virus.

She was discharged on Wednesday from the Royal Free Hospital in London, which has Britain’s only high-level isolation ward for the treatment of infectious diseases, the hospital announced on Thursday. She was transferred for additional care to Queen Elizabeth University Hospital in Glasgow.

Ms. Cafferkey was the second person found to have Ebola in Britain. . . .

Gilead's response last month does typify the new pull-quote on my masthead. Kudos to all involved -- Merck earlier, throughout Africa, and Gilead these past few weeks! Onward, on a blustery Thursday walk in. . . .

Tuesday, November 10, 2015

Boulder's míRagen® Therapeutics Secures $41 Million Equity Round, From Merck-Affiliated Venture Fund

míRagen is a Colorado based developmental stage entity -- the therapeutic candidates of which are designed to target microRNAs, a class of small RNA molecules that regulate gene expression, and that can serve as potential indicators of disease. Were I betting, I might bet that MRL Ventures is interested in the potential to marry some future míRagen developed therapeutic (or test-marker), to Merck's Keytruda® -- and help treat/predict how cancer patients might be able to benefit most-robustly, from that new therapy. . . . We shall see.

I could certainly be mistaken, though -- about that above guess. In any event (complete with a nice Flatirons underlay image), is a graphic, and the story -- out of the Denver Post, this morning:

. . . .MíRagen Therapeutics Inc., a Boulder-based biopharma specializing in developing drugs targeting small ribonucleic acid molecules, landed $41 million in financing to bring two of its drug candidates into clinical development. . . .

MíRagen officials on Tuesday announced that the preferred stock financing led in part by a Merck venture fund would advance programs in the areas of hematological malignancies and pathological fibrosis. The drug targets miRagen intends to bring through clinical development are MRG-106 and MRG-201.. . .

These amounts (anything under $100 million) are clearly rounding errors, to Kenilworth, but may lead to a significant new product class, or a test for one. So, the bet is a good one (plus it leads to ski weekends, on the ensuing update/diligendce trips). Onward -- on a flawless Tuesday -- hunting for good soup. . . . Smile!

Monday, November 9, 2015

Will Bridion® (sugammadex) FINALLY Win Approval (On Fourth Try: 12.19.2015) -- At FDA?

We have covered, for at least seven years, the intrepid path of sugammadex, one of former Schering-Plough CEO Fred Hassan's 2007-2008 "Five Stars." Back then he was touting a likely 2009 approval. If he's lucky, it might -- just might -- make approval in the US before the end of 2015. And even then, the concerns with rather rare, but troubling, allergic reactions in the Operating Room Suites seem to continue -- in Europe, where it has been approved for over three years, now. This is clearly going to be an immaterial US franchise for Kenilworth, if approved, but it is some good news, nonetheless.

Here is a bit from BioPharmaDive, on it:

. . . .Seven months ago, Bridion was rejected by the FDA's reviewing panel for the third time. The concern was 'hypersensitivity' to the drug, and because the drug had already been used in the E.U. for some time, there were numerous case reports to attest to this risk. . . .

The FDA is not bound by the committee’s guidance but takes its advice into consideration when reviewing investigational medicines. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review of Bridion is December 19, 2015. . . .

It is (in my opinion) probable that the US label-copy will contain strong warnings -- about watching for patients' allergic reactions while under heavy sedation, in the OR. Onward, we go, in any event -- on a perfect fall Monday afternoon!

Saturday, November 7, 2015

"These are not the droids you are looking for" -- Gilead Channels Obi-Wan -- In Photo-Tube Flap, Over Solvaldi® (sofosbuvir) Patents

About twelve days ago, I highlighted some unusual Saturday federal court filings by Merck's lawyers, in this truly massive, sprawling (globe spanning, actually) patent battle -- which if ultimately decided on the merits -- could generate (or cost) literally billions in revenue -- on sofosbuvir, for the two parties in interest: Gilead and Merck. Late on Friday, Gilead's answer appeared in the electronic patent dockets, to Merck's motion to compel.

In sum, you got the wrong guy, man -- is the answer. Or, as December 18 looms, brightly -- "These are not the droids you are looking for. . ."

[Please forgive the dated reference, there. Smile. Updated PG-13 parody clip, below.] In any event, here is the full 26 page PDF of Gilead's Response -- and a bit:

. . . .Merck’s request is rooted in a demonstrably wrong assertion — that the material in one of the Photographed Tubes is PSI-6130. Merck makes that assertion in the face of overwhelming evidence that PSI-6130 did not exist in October of 2002 and based solely on the unremarkable fact that one of the tubes contains material with a molecular weight identical to PSI-6130’s weight of 259.2. However, Merck is already in possession of information clearly identifying the compound in question as PSI-0194 — a compound having a distinctly different structure from PSI-6130, but sharing its molecular weight. Merck had this information before filing its October 23, 2015 Motion to Compel Plaintiff and Dr. Seeger to Comply with Discovery Requests and Subpoena (the “Motion”). Additionally, after Merck filed its Motion, Gilead provided additional evidence unambiguously identifying the material in the Photographed Tubes as including PSI-0194, and excluding PSI-6130.

Nonetheless, despite Gilead’s requests, Merck has refused to withdraw its Motion, unreasonably forcing Gilead to incur the costs of opposing Merck’s meritless demands. . . .

If you are so inclined, do go read it all -- but that is the sum and substance -- mistaken identity. So, Merck has no new leg up, here. Off -- to enjoy a flawless, SoFA glass sculptures filled Saturday, now. Smile.

Friday, November 6, 2015

As Of Tomorrow, Sierra Leone Is... Ebola-Free

UPDATED: Ebola epidemic has ended in Sierra Leone. That is very good news. And we should celebrate it -- as we do whenever science and human life finds a way -- over adversity.

But in the same moment, we must acknowledge that the life form called ebola (a virus). . . finds a way, too. During the past week, one active case in Guinea, a mother, died after child-birth -- and her newborn replaced her, on the W.H.O. lists, as an infection case -- so the total in the outlying Forecariah prefecture -- and in Guinea -- remains (in an unspeakably tragic way) steady, at three. Despite the pending good news in Sierra Leone, the story in the tiny rural village of Tana, in Forecariah Prefecture, Guinea is the front page of The New York Times, this morning:

. . . .The prime minister had arrived, and he was there to give this rural community a serious scolding.

“I demand the cooperation of the population,” said the prime minister, Mohamed Said Fofana, nearly hollering from his perch on a makeshift bamboo stage.

“Ebola is gone everywhere — except here,” Mr. Fofana told the nearly 300 people gathered around him. “The eyes of the world are on Tana village.”

This is the last known place on Earth with Ebola. . . .

Getting to zero — as the effort to finally stop the outbreak is known — has bedeviled governments and international health experts for months. Workers from aid groups have descended on the villages where the virus is still spreading, a promising experimental [Merck/NewLink] vaccine is being given to adults who have been in contact with a victim, and government officials, once reluctant to acknowledge the dangerous outbreak, are helping to wipe it out. . . .

We will certainly meditate -- to keep all mothers, expecting and delivered -- awash in golden hued good ju-ju, this weekend. Namaste. . . .

Small Civil Dulera® Pricing Investigation Disclosed In Latest Form 10-Q

Rather late last evening, Kenilworth filed its Q3 SEC Form 10-Q -- and at page 22 we find a new government investigation. There is no indication as to when the US Attorney from the Eastern District of Pennsylvania came knocking with this CID, but I'll bet a dollar that it wasn't long after Martin Shkreli's antics became public fodder. I say this because it looks to be very recent -- and Lilly received one as well.

Regular readers will recall that Dulera® was a legacy Schering-Plough product, FDA approved in 2010. In late 2010, once it controlled Schering-Plough's legacy products -- Merck withdrew its application in the EU for approval of an aersolized fixed dose combo version, for a host of reasons. So it goes:

. . . .The Company has received a civil investigative demand from the U.S. Attorney’s Office, Eastern District of Pennsylvania which requests information relating to the Company’s contracting and pricing of Dulera Inhalation Aerosol with certain pharmacy benefit managers and Medicare Part D plans. The Company is cooperating with the investigation. . . .

Morning, one and all! Onward!

Thursday, November 5, 2015

While We Wait For Pfizer To File Its Now (Allegedly) Quite Tardy Q3 2015 LD-2 Lobbying Disclosure. . .

Pfizer apparently occasionaly waits until February or March of the next ensuing calendar year to file its (prior year's) Q3 LD-2 -- lobby expenditure/ disclosure form. It seems to file the first, second and fourth quarter ones generally on time -- but about every second year, it waits past the New Year -- to file its third quarter report. Odd. And it generally does so, by claiming an amendment. I am not a pure specialist in this arcane area of the law, but on a review, I see nothing that permits such a delay -- in fact, the scheme contemplates robustly prompt filings (without any explicit authority for waivers)1.

The rules in fact further contemplate that a registrant like Pfizer at least file a notice that it is going to be late, and explain the reasons for the tardiness, as I read it. Even so, the tardy filing won't be excused, without some additional (but apparently unspecified) liability. [Does it pay a fine? That seems. . . unclear.] As I say -- odd.

[My weekend backgrounder here; but there will be another post (a right full and proper Part II), on the evolution of so-called inversion-regulation -- related to the potential for a $100-plus billion Allergan deal -- since we last visited the topic when Pfizer was attempting a semi-, evolving to fully- hostile maneuver to take over Astra-Zeneca, and then nominally re-incorporate in AZ's home country, and reap vast US tax abatement windfalls, during 2014.]

However, while we wait -- we do already know that the lobby-firm Williams and Jensen, PLLC lobbied for Pfizer during the third quarter of 2015 (as it timely filed with the US Senate office of disclosure -- to the tune of an annualized $320,000 per year), on:

. . . .[Lobbied US Senate and US House of Representaives about. . .] Tax issues affecting the pharmaceutical industry including international tax. Revenue proposals on international tax. Comprehensive tax reform proposals. . . .

That bit of text would plainly cover loosening of the newly tightened inversion rules -- as part of the scheme of corporate taxation of multinationals inside the US. So, Ian Read has been a busy fella', in the halls of Congress this year -- but we may not know precisely just how busy -- until early 2016. And by then, he may have won his Allergan inversion-fueled prize. Ugh. Now you know -- and as ever, onward -- on a perfect fall 70 degree day!


1 Viz., US Senate S1-Guidance PDF file (page 13 of 2008 edition) "...The Secretary and Clerk do not have the authority under the LDA to grant extensions to registrants.

The obligation to report under the LDA arises from active status as a registrant (i.e., a registration on file that has not been validly terminated). Section 5(a) of the LDA requires a registrant to file a report for the quarterly period in which it incurred its registration requirement, and for each quarterly period thereafter, through and including the reporting period encompassing the date of registration termination. A timely report using Form LD-2 is required even though the registration was in effect for only part of the reporting period....

Tuesday, November 3, 2015

Propecia® MDL Status: Newly-Revised Pre-Trial Conference Schedule [Updated]

This is just a smallish update -- to the schedule laid out generally, here. A new Magistrate Judge has been assigned to the MDL -- and the first pre-trial conference has been reset, to a new date, in turn (in blue below).

Even so, no actual trials on the merits, before a jury, are expected before September 2017. We will keep a weather eye on the horizon -- for any sign of how the good doctor's production hearing turned out -- though I will note for the record that several people from her institution did visit repeatedly here, just yesterday. So that led me to this update -- Thanks!

. . . .The Pretrial Conference originally scheduled before Magistrate Judge Viktor V. Pohorelsky has been rescheduled to 12/3/2015 02:00 PM in Courtroom 322 North before Magistrate Judge Peggy Kuo.

The MDL and all pending member cases have now been reassigned to Magistrate Judge Peggy Kuo Associated Cases: 1:12-md-02331-JG-PK et al. . . .

Now you know. Smiling widely -- while looking back. . . with joy some three. . . and eighteen, and thirty six. . .

Monday, November 2, 2015

Keytruda® Gets New FDA Breakthrough Designation In Relatively Narrow Set Of Colorectal Cancers -- Smallish Good News

This is clearly welcome news -- for Kenilworth -- but it covers only about a fifth (give or take), of all current colorectal oncology cases. And the underlying study, called "Keynote-164", is still in Phase II.

But we note it -- as more step by step evidence that Merck has an important new oncology product/candidate franchise here. [As ever, BMS is out ahead -- but there will be multiple billions in annual revenue available to Merck, even as the "second place" overall finisher.] Here's a bit of the morning's press release:

. . . .Testing tumors for microsatellite instability can identify patients with defective DNA mismatch repair (MMR) systems. DNA MMR is a process that permits cells to recognize and repair genetic mismatches generated during DNA replication. A defective MMR system allows mismatch mutations to persist. The average tumor has dozens of mutations; however tumors with DNA MMR deficiency may harbor thousands, especially in regions of repetitive DNA known as microsatellites. Tumors that are found to have mutations in select microsatellite sequences, called microsatellite instability (MSI), are considered DNA MMR-deficient. These tumors are referred to as being “MSI high.” Overall, DNA MMR-deficiency is present in approximately 15-20 percent in Stage II disease, 10 percent in Stage III disease and approximately 5 percent or less in Stage IV disease. In colorectal cancers, MMR-deficiency is seen in approximately 15-20 percent of non-hereditary colorectal cancers and in most hereditary colorectal cancers associated with Lynch Syndrome.

Merck is conducting a Phase 2 registration study (KEYNOTE-164) to evaluate the efficacy and safety of KEYTRUDA based on microsatellite instability status in patients with previously treated advanced colorectal cancers, and is also planning a Phase 3 study (KEYNOTE-177) in a treatment naïve patient population. . . .

Now you know -- and we will keep an eye on Keynotes-164 and -177. 'Tis a perfectly sunny fall day here. . . so I am grinning, ear to ear!